{"entity":{"id":"nct04488822","kind":"trial","name":"A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT","aka":[],"tldr":"A phase 3 trial of Pexidartinib in tenosynovial giant cell tumour, run by Daiichi Sankyo Co., Ltd., active and no longer recruiting.","summary":"A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT is a phase 3 interventional study registered as NCT04488822 by Daiichi Sankyo Co., Ltd., with 40 participants enrolled, started 2020-09-25 and due to reach its primary completion in 2021-10-27. Interventions recorded: Pexidartinib. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04488822","url":"https://clinicaltrials.gov/study/NCT04488822"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tenosynovial-giant-cell-tumour"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["pexidartinib"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04488822","phase":"3","setting":"Multicenter, Single Arm Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor","sponsor":"Daiichi Sankyo Co., Ltd.","started":"2020-09-25","startedType":"actual","yearReported":2023,"enrolled":40,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Response Rate (ORR) of Pexidartinib Based on RECIST 1.1 of Asian Participants With Symptomatic Tenosynovial Giant Cell Tumor (TGCT) at Week 25, ORR","primary":true,"unit":"participants","arms":[{"name":"Pexidartinib","n":40,"value":9,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-04-27), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04488822?tab=results"}]},"route":"/trials/nct04488822/","neighbours":{"cancer":[{"id":"tenosynovial-giant-cell-tumour","kind":"cancer","name":"Tenosynovial giant cell tumour (TGCT)","route":"/cancers/tenosynovial-giant-cell-tumour/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"pexidartinib","kind":"drug","name":"Pexidartinib","route":"/drugs/pexidartinib/"}],"company":[{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"}]}}